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A Phase I Study of BKM120 and Olaparib in Patients with High-Grade Serous Ovarian Cancer

Full Title

Phase I Study of the Oral PI3Kinase Inhibitor BKM120 or BYL719 and the Oral PARP Inhibitor Olaparib in Patients with Recurrent Triple Negative Breast Cancer or High Grade Serous Ovarian Cancer

Purpose

BKM120 is an investigational drug that blocks a molecule called PI3 kinase, which appears to function abnormally in many cancers. Olaparib kills cancer cells by blocking the PARP protein, thereby preventing the repair of DNA or genetic damage in cancer cells and possibly making them more vulnerable to anticancer treatments. Prior research has shown that both of these drugs may have activity against high-grade ovarian cancer.

The purpose of this study is to find the optimal doses for giving both BKM120 and olaparib in combination in women with high-grade serous cancer of the ovaries, fallopian tubes, or peritoneum (abdominal cavity) that has recurred despite standard therapy.

Both BKM120 and olaparib are taken orally (by mouth).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

Patients must have high-grade serous cancer of the ovaries, fallopian tubes, or peritoneum that has recurred despite standard therapy.

At least 4 weeks must have passed since completion of chemotherapy and 3 weeks since any radiation therapy and entry into the study, and patients must have recovered from any serious side effects.

Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.